Status:
ENROLLING_BY_INVITATION
Bryophyllum Pinnatum Tea as a Novel Treatment for Recurrent Kidney Stone Formers
Lead Sponsor:
Indra Gupta
Conditions:
Kidney Calculi
Calcium Oxalate Kidney Stones
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
The aim of this randomized placebo-controlled double-blind crossover clinical trial is to test the ability of a traditional tea made from the leaf of the Bryophyllum pinnatum (B. pinnatum) plant in de...
Detailed Description
Background and Rationale: Kidney stones are hard deposits that consist of calcium complexed with phosphate or oxalate, thus, high urinary calcium content is a major risk factor. The precipitation of ...
Eligibility Criteria
Inclusion
- 18-70 years of age at time of study enrollment
- 1 calcium-based stone event within a 3-year interval and/or hypercalciuria on a 24h urine collection (\>5 mmol/day)
- They had an ultrasound or CT imaging within the previous 6 months which showed no evidence of current obstructive kidney stone
- Adhering to the stone prevention diet (high water/low salt/low protein intake) for at least one month prior to enrollment in study but not taking any stone-preventing medications
- Agrees to maintain current lifestyle habits and avoid taking new supplements during the study period
Exclusion
- Patients with secondary causes for calcium stone formation (primary hyperparathyroidism, inflammatory bowel disease, hyperuricosuria, and cancer)
- Patients who are pregnant or nursing or who are trying to become pregnant
- Currently consuming B. pinnatum or any natural health product containing polyphenols
- A known intolerance or allergy to the plant B. pinnatum
- Currently taking stone-preventing medication
- Gluten intolerance or allergy
Key Trial Info
Start Date :
November 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06987084
Start Date
November 7 2024
End Date
December 31 2025
Last Update
May 23 2025
Active Locations (1)
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1
McGill University Health Centre (Glen Site)
Montreal, Quebec, Canada, H4A 3J1